AsthmaAsthmaNCT02435394
Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement
A study testing Remote Coach plus Asthma Module, Asthma Module- No Coach and CHADIS- no Asthma Module in people with Asthma, run by Total Child Health, Inc. at 1 site in United States.
Trial summary
Asthma, one of the most common pediatric illnesses, is optimally managed according to National Heart Lung and Blood Institute (NHLBI) guidelines yet this is not often done in primary care. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Asthma
- What is being tested?
- Remote Coach plus Asthma Module, Asthma Module- No Coach and CHADIS- no Asthma Module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Asthma diagnosis
Who cannot join
- Not English or Spanish speaking
Trial locations and contacts
1 site in 1 country.
About this study
Asthma, one of the most common pediatric illnesses, is optimally managed according to National Heart Lung and Blood Institute (NHLBI) guidelines yet this is not often done in primary care. This project is to develop and test the effects of using a module for guideline based care in the Child Health and Development Interactive System (CHADIS) online system by prompting and incorporating patient symptom/control and adherence data from standard questionnaires to inform visits and providing automated patient specific education and Asthma Action Plans in individual Care Portals.
Read the detailed description
We will complete the formative work collecting professional opinion to create and pilot the initial CHADIS Asthma Intervention module (CHADIS-AI), an innovative decision support system. CHADIS-AI content will be assembled and vetted by asthma experts and primary care providers (PCPs). Parent and teen focus groups will vet the content and language of the adherence materials and Care Portal. A system will also be established for points for patient participation, to give clinicians Maintenance of Certification (MOC) credit, and ongoing run chart reports of their patients' asthma status for continual Quality Improvement (QI) feedback. The resulting system will be pilot tested and refined by clinician feedback. Practices will be randomly assigned to intervention vs control. Control practices will use CHADIS for asthma care without the A-I module. Intervention practices will be further randomized to have remote coach support for patients or not. Outcomes will be examined of asthma severity/control, match of severity with guideline based medication management, numbers of Emergency Department (ED) visits, hospitalizations and oral steroid use. Effect of remote coaching will also be assessed.
- Conditions
- Asthma
- Being tested
- Remote Coach plus Asthma Module, Asthma Module- No Coach, CHADIS- no Asthma Module
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Coach plus Asthma ModuleBehavioural
Also called Remote Coach
The intervention is for a remote coach to assist patients with asthma for practices which will use Asthma module for guidance for asthma care.
Asthma Module- No CoachBehavioural
The intervention is for practices to use the Asthma module for guidance for asthma care without assistance by a remote coach.
CHADIS- no Asthma ModuleBehavioural
The practices will use the general CHADIS tool without access to the Asthma Module add-on to assist in asthma care.
| Study group | Role | What they receive |
|---|---|---|
| Remote Coach plus Asthma Module | Experimental | The intervention is for practices to have remote coach support for patients with asthma in addition to doctors using CHADIS-Asthma module. Practices will start sequentially for a time series analysis. Receives: Behavioral: Remote Coach plus Asthma Module |
| Asthma Module- No Coach | Experimental | The intervention is for practices to use CHADIS-Asthma module to improve patient care without a remote coach assisting patient adherence. Receives: Behavioral: Asthma Module- No Coach |
| CHADIS- no Asthma module | Active comparator | Practices using CHADIS but no Asthma module as a control condition. Receives: Behavioral: CHADIS- no Asthma Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
NHLBI recommended controller meds used
match between severity rating and NHLBI recommended med mgt
Measured: 3-12 months
Secondary outcomes (6)
Emergency department visits
Self reported interval ED visits
Measured: 3-12 months
Asthma trigger mitigation
self-reported efforts to reduce asthma triggers
Measured: 3-12 months
Hospitalizations for asthma
Self reported hospitalizations
Measured: 3-12 months
Steroid bursts
Self reported use of steroid bursts for asthma exacerbations
Measured: 3-12 months
Influenza vaccine receipt
self reported receipt of flu vaccine for this season
Measured: 3-12 months
asthma symptom control
severity/control ratings
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: After IRB review, this study is no longer considered a clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Total Child Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Barbara J Howard, MD, Principal investigator, Total Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435394
- Sponsor's protocol ID
- 1R44HL117482
- Acronym
- Asthma
- Status last verified
- Apr 2016
- First submitted
- 28 Apr 2015
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement
- ClinicalTrials.gov ID
- NCT02435394
- Acronym / sponsor ID
- Asthma / 1R44HL117482
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: After IRB review, this study is no longer considered a clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Total Child Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma, one of the most common pediatric illnesses, is optimally managed according to National Heart Lung and Blood Institute (NHLBI) guidelines yet this is not often done in primary care. This project is to develop and test the effects of using a module for guideline based care in the Child Health and Development Interactive System (CHADIS) online system by prompting and incorporating patient symptom/control and adherence data from standard questionnaires to inform visits and providing automated patient specific education and Asthma Action Plans in individual Care Portals.
Detailed description
We will complete the formative work collecting professional opinion to create and pilot the initial CHADIS Asthma Intervention module (CHADIS-AI), an innovative decision support system. CHADIS-AI content will be assembled and vetted by asthma experts and primary care providers (PCPs). Parent and teen focus groups will vet the content and language of the adherence materials and Care Portal. A system will also be established for points for patient participation, to give clinicians Maintenance of Certification (MOC) credit, and ongoing run chart reports of their patients' asthma status for continual Quality Improvement (QI) feedback. The resulting system will be pilot tested and refined by clinician feedback. Practices will be randomly assigned to intervention vs control. Control practices will use CHADIS for asthma care without the A-I module. Intervention practices will be further randomized to have remote coach support for patients or not. Outcomes will be examined of asthma severity/control, match of severity with guideline based medication management, numbers of Emergency Department (ED) visits, hospitalizations and oral steroid use. Effect of remote coaching will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remote Coach plus Asthma Module | Experimental | Behavioral: Remote Coach plus Asthma ModuleThe intervention is for practices to have remote coach support for patients with asthma in addition to doctors using CHADIS-Asthma module. Practices will start sequentially for a time series analysis. |
| Asthma Module- No Coach | Experimental | Behavioral: Asthma Module- No CoachThe intervention is for practices to use CHADIS-Asthma module to improve patient care without a remote coach assisting patient adherence. |
| CHADIS- no Asthma module | Active comparator | Behavioral: CHADIS- no Asthma ModulePractices using CHADIS but no Asthma module as a control condition. |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Asthma diagnosis
Key exclusion criteria (1 listed)
- Not English or Spanish speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Coach plus Asthma ModuleAlso: Remote CoachThe intervention is for a remote coach to assist patients with asthma for practices which will use Asthma module for guidance for asthma care. | Behavioural | Remote Coach plus Asthma Module |
| Asthma Module- No CoachThe intervention is for practices to use the Asthma module for guidance for asthma care without assistance by a remote coach. | Behavioural | Asthma Module- No Coach |
| CHADIS- no Asthma ModuleThe practices will use the general CHADIS tool without access to the Asthma Module add-on to assist in asthma care. | Behavioural | CHADIS- no Asthma module |
Primary outcome
NHLBI recommended controller meds used
Time frame: 3-12 months
match between severity rating and NHLBI recommended med mgt
6 secondary outcomes
Emergency department visits
Time frame: 3-12 months
Asthma trigger mitigation
Time frame: 3-12 months
Hospitalizations for asthma
Time frame: 3-12 months
Steroid bursts
Time frame: 3-12 months
Influenza vaccine receipt
Time frame: 3-12 months
asthma symptom control
Time frame: 3-12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara J Howard, MD principal investigator
Total Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Coach plus Asthma Module, Asthma Module- No Coach and CHADIS- no Asthma Module in people with Asthma, run by Total Child Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NHLBI recommended controller meds used (time frame: 3-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.